Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05492916
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2022-08-05
Brief Title:
Integrating Cultural Aspects Into Diabetes Education
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
INCLUDE INtegrating CuLtUral Aspects Into Diabetes Education
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCLUDE
Brief Summary:
The goal of this study is to examine the efficacy of the video-based Diabetes Prevention Program DPP Community-supported agriculture CSA hereafter INCLUDE intervention compared with a wait-list control group hereafter CONTROL on diabetes prevention among Chinese immigrants with T2D in NYC Participants will be randomized with equal allocation to one of the two groups The INCLUDE group will receive one culturally tailored DPP brief videoweek for 24 weeks delivered via WeChat They will also have access to the CSA program that Co-I Dr Stella Yi has built in existing and ongoing community-partnered work in Brooklyn Chinatown The CONTROL group will continue to receive their usual care and at the end of the study they will receive DPP videos Measurements will occur at baseline 3 and 6 months This study will provide critical information on whether it is efficacious to use an existing social media platform plus CSA support to enhance access to DPP If the intervention is proven efficacious this project can provide important data for future scaling of this intervention This study may serve as a transformative new model to enhance access to culturally tailored diabetes education and promote health equity for underserved limited English proficiency LEP immigrant and minority groups
Detailed Description:
Chinese immigrants are the second largest immigrant group in the US who suffer disproportionately high type 2 diabetes T2D burden and have poor diabetes outcomes The Diabetes Prevention Program DPP is an evidence-based intervention to prevent or delay T2D However many social determinants of health SDOH barriers limit the access of DPP to underserved Chinese immigrants including high rates of LEP poverty lack of health insurance and poor access to care Furthermore there is a significant shortage of cultural- and linguistic-concordant providers to deliver DPP Given the high T2D burden and rapid growth in the Chinese immigrant population there is an urgent need for research to make DPP accessible to this minority group High social media use eg WeChat in Chinese immigrants suggests a promising mechanism for enhancing access to DPP Yet this mobile health mHealth intervention alone is likely insufficient to address many SDOH barriers reported by LEP Chinese immigrants including food insecurity and lack of access to fruits and vegetables Community-supported agriculture CSA has been demonstrated to be an effective way to improve food security in White populations and may help to address food access issues in LEP Chinese immigrants Guided by the NIMHD Research Framework the investigators argue that a mHealth DPP intervention individual level that is supplemented with a culturally appropriate CSA community level with complementary nutritionproduce preparation education is a novel model for enhancing access to DPP and addressing SDOH barriers in LEP Chinese immigrants The investigators pilot work demonstrates the feasibility acceptability and potential efficacy of WeChat-delivered educational videos targeting T2D management and Co-I Dr Stella Yis pilot study has found high feasibility of the CSA model in LEP Chinese immigrants Building upon these pilot data the investigators will adapt their current T2D management intervention to include video content relevant to DPP and combine it with a CSA model The goal of this study is to examine the efficacy of the video-based DPPCSA hereafter INCLUDE intervention compared with a wait-list control group hereafter CONTROL on diabetes prevention among Chinese immigrants with T2D in NYC Participants will be randomized with equal allocation to one of the two groups The INCLUDE group will receive one culturally tailored DPP brief videoweek for 24 weeks delivered via WeChat They will also have access to the CSA program that Co-I Dr Stella Yi has built in existing and ongoing community-partnered work in Brooklyn Chinatown The CONTROL group will continue to receive their usual care and at the end of the study they will receive DPP videos Measurements will occur at baseline 3 and 6 months This study will provide critical information on whether it is efficacious to use an existing social media platform plus CSA support to enhance access to DPP If the intervention is proven efficacious this project can provide important data for future scaling of this intervention This study may serve as a transformative new model to enhance access to culturally tailored diabetes education and promote health equity for underserved LEP immigrant and minority groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None